Universal Laser Systems Co Ltd.
⚠️ High Risk
FEI: 3010843785 • Yokohama-shi, Kanagawa-ken • JAPAN
FEI Number
3010843785
Location
Yokohama-shi, Kanagawa-ken
Country
JAPANAddress
Landmark Tower 15f 2 2 1 1 Minatomirai, , Yokohama-shi, Kanagawa-ken, Japan
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
NON STD
The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/10/2025 | 95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL | 47NON STD | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Universal Laser Systems Co Ltd.'s FDA import refusal history?
Universal Laser Systems Co Ltd. (FEI: 3010843785) has 1 FDA import refusal record(s) in our database, spanning from 11/10/2025 to 11/10/2025.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Universal Laser Systems Co Ltd.'s FEI number is 3010843785.
What types of violations has Universal Laser Systems Co Ltd. received?
Universal Laser Systems Co Ltd. has been cited for 1 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Universal Laser Systems Co Ltd. come from?
All FDA import refusal data for Universal Laser Systems Co Ltd. is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.